Universal External Control Device for Use by Multiple Conditional Access Users With Varying Access to Functionality of an Implantable Medical Device

ABSTRACT

A universal external control device for use by multiple conditional access users with varying access to functionality of an implantable medical device in wireless communication therewith. Circuitry associated with the external control device is used to uniquely identify each of the conditional access users via an access device such as a key or card. Access to functionality of the implantable medical device is restricted by the universal external control device based on the conditional access user identified by the access device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 11/586,479, filed Oct. 25, 2006, which is hereinincorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

An external control device for wirelessly controlling an implantablemedical device, and in particular, to a universal or common externalcontrol device for use by multiple conditional access users each ofwhich has varied access to functionality of the implantable medicaldevice.

2. Description of Related Art

When controlling an implantable medical device it is often desirable tolimit or restrict access of certain functionality to specific users. Forexample, in the case of a device for the dispensing of fluid medicationit is imperative that the patient be restricted in the volume ofmedication to be dispensed; otherwise, serious health risks or possibledrug dependency may result.

U.S. Pat. No. 6,126,642 is directed to a patient controlled intravenousfluid dispenser for controllably dispensing fluid medicament, e.g., painkilling drugs, intravenously at a selected uniform rate. To positivelyregulate the patient administration of the medicament, the doseintervals at which a selected medicament can be administered, as well asthe volume of the dose of the medicament to be administered, is presetonly by an authorized person such as the treating physician and, onceset, cannot be altered by the patient. The device setting can only beoperated or adjusted by an all mechanical mechanism, i.e., by a smallphysical physician's key that remains in the possession and control ofthe treating physician or health care worker. Specifically, the patentedpatient controlled analgesia device has dispensing means that includestwo manually rotatable control knobs 34, 37, one of which is used tocontrol the dose volume while the other is used to adjust the doseinterval. Both rotating knobs are carried by a common operating rod.Locking means are provided for preventing rotation of control knobs 34and 37 unless and until a locking rod, which comprises a part of thelocking means, is moved from a locked position to an unlocked positionvia a locking key inserted into the device. In the locked position thelocking rod prevents rotation of the control members. However, when thelocking rod is slid to its unlocked position the control knobs can befreely rotated by the treating physician to precisely preset the volumeof each dose of medicament to be delivered and preset the intervalbetween doses.

A physical locking key having all mechanical parts is possible in thepatented system because the intravenous fluid dispenser and its controlknobs are located externally of the patient's body. In the case of animplantable medical device controlled wireless by an external controldevice, an all mechanical construction such as that in the patentedsystem would not be possible since the control knobs on the externaldevice have no physical interaction with the parts of the implantablemedical device.

In the patented intravenous fluid dispenser, access to a single level offunctionality (e.g., adjustment of the control knobs) is varied betweenone of two states (unlocked/accessible state versus locked/prohibitedstate). The system is therefore designed to only distinguish or restrictaccess of a single set or class of functions (e.g., adjustment of thecontrol knobs) between these two states. By default, when the lockingrod is in the first locked position patient adjustment of the controlknobs is prohibited. It is only when the locking key is physicallyinserted into the device and the locking rod is slid to its secondunlocked position (unlocked/accessible state) that the controls knobscan be rotated by the treating physician. Therefore, the patentedpatient controlled intravenous fluid dispenser is only suitable for asingle user, e.g., the physician, having conditional access. Inalternative applications, apart from the patient, conditional access toparticular functionality may be warranted by more than one user. Forinstance, it is possible that users other than the physician should beable to adjust the control knobs but also be provided access tofunctionality that otherwise may remain prohibited by the physician.Modification of the patented device to accommodate multiple conditionalaccess users having access to varied, but sometimes overlapping,functionality would require a physical key for each function tomechanically prohibit or permit access to the particular activity. Inthe case of more than one function this would disadvantageously requireeach conditional access user to carry multiple keys, wherein each keyhas a unique physical design to mechanically unlock parts associatedwith a single function.

It is therefore desirable to design a universal external control devicefor wireless control of an implantable medical device whosefunctionality is conditionally accessible by multiple conditional accessusers, without the use of multiple keys one for each function or amechanical locking mechanism associated with the implantable medicaldevice.

SUMMARY OF THE INVENTION

It is an object of the present invention to develop a universal externalcontrol device for limiting or restricting control of particularfunctionality of the implantable medical device among multipleconditional access users without having to physically carry aroundmultiple keys one for each function or the need for a mechanical lockingmechanism associated with the implantable medical device.

Another object of the present invention is to develop a universalexternal control device for limiting or restricting control ofparticular functionality of the implantable medical device amongmultiple conditional access users, wherein each user is assigned to aconditional functional access level from a hierarchical framework ofmultiple conditional functional access levels.

Still another object of the present invention is to develop a universalexternal control device for limiting or restricting control ofparticular functionality of the implantable medical device amongmultiple conditional access users, wherein each user is assigned to aset of accessible functions from a non-hierarchical framework ofmultiple conditional accessible functions.

A universal external control device is described herein for use bymultiple conditional access users with varying access to functionalityof an implantable medical device in wireless communication with theexternal control device. Circuitry associated with the external controldevice is used to uniquely identify each of the conditional access usersvia an access device such as a key or card. Access to functionality ofthe implantable medical device is restricted by the universal externalcontrol device based on the conditional access user identified by theaccess device.

The present invention relates to a universal external control devicepermitting wireless conditional access to functionality of animplantable medical device by a plurality of conditional access users.The external control device includes circuitry for identifying each ofthe plural conditional access users, determining functionalityassociated with the implantable medical device which each of the pluralconditional access users has been assigned and restricting access foreach of the plural conditional access users to that functionalityassociated with the implantable medical device based on the determinedfunctionality to which each of the plural conditional access users hasbeen assigned.

In addition, the invention is directed to a system for wirelessconditional access to functionality of an implantable medical device bya plurality of conditional access users using a universal externalcontrol device. The system includes a plurality of access devices onefor identifying each of the plural conditional access users. Circuitryis utilized for determining functionality associated with theimplantable medical device which each of the plural conditional accessusers has been assigned and restricting access for each of the pluralconditional access users to that functionality associated with theimplantable medical device based on the determined functionality towhich each of the plural conditional access users has been assigned.

Furthermore, the present invention relates to a method for using theuniversal external control device as described above. Each of the pluralconditional access users is assigned functionality associated with theimplantable medical device to which that user is permitted conditionalaccess. The external control device is used to determined functionalityassociated with the implantable medical device which each of the pluralconditional access users has been assigned. Access to the functionalityassociated with the implantable medical device for each of the pluralconditional access users is then restricted based on the determinedfunctionality to which each of the plural conditional access users ispermitted conditional access.

BRIEF DESCRIPTION OF THE DRAWING

The foregoing and other features of the present invention will be morereadily apparent from the following detailed description and drawings ofillustrative embodiments of the invention wherein like reference numbersrefer to similar elements throughout the several views and in which:

FIG. 1 a is an exemplary embodiment of the universal external controldevice in communication with an implantable medical device in accordancewith the present invention;

FIGS. 1 b through 1 e are exemplary embodiments of the access device inFIG. 1 a that identifies the user based on the number of magnets andtheir arrangement;

FIG. 2 is an exemplary Venn diagram depicting a hierarchical frameworkof three access function levels associated with three differentconditional access users in accordance with the present invention;

FIG. 3 is an exemplary Venn depicting a non-hierarchical framework ofvaried access to functionality among four conditional access users; and

FIG. 4 is a flow diagram of the steps taken in the operation of auniversal external control device wherein conditional access tofunctionality of an implantable medical device varies based on theconditional access user.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS OF THEINVENTION

The present invention is directed to a system and method for restrictingaccess to functionality of an implantable medical device among multipleconditional access users using a universal external control devicewithout the need for a mechanical locking mechanism associated with theimplantable medical device or a physical key for each function. Use of asingle universal external control device to be used by multiple usersreduces inventory and production of different external control devices,one for each user. The implantable medical device in accordance with thepresent invention is accessible by numerous users. Typically, apatient's access is restricted to default non-conditional functionalityof the implantable medical device which all other users also have accesswithout restriction. Therefore, the patient is classified as anon-conditional access user in that no conditions are in place topreclude access to that functionality of which the patient has access.Multiple other individuals or users are referred to as conditionalaccess users in that each has access to functionality which is availableonly upon first satisfying a condition. Typically, the condition iswhether that individual or user has been authorized, assigned orpermitted in advance to access such functionality.

In the exemplary embodiment shown and described the implantable medicaldevice is a drug infusion pump. The present inventive universal externalcontrol device, however, is suitable for use with other implantablemedical devices such as, but not limited to, a stimulator or sensor.

Functionality associated with the drug infusion pump to be adjusted orcontrolled may include any one or more of the following: (i) settingdosage volume of medication to be dispensed, (ii) setting time intervalbetween dispensing of medication, (iii) self-testing of the druginfusion pump to ensure or verify that it is operating properly, (iv)resetting of system parameters, (v) entering of stored information aboutthe name of the medication, (vi) setting stored drug concentration,(vii) entering of stored information about the patient (e.g., name,address, age), (viii) entering of stored information about theimplantation of the pump (e.g., date, name of hospital, physician), (ix)entering of stored information about the catheter connected to the pump(e.g., manufacturer, type of catheter, length of the catheter, internalvolume of the catheter), and (x) setting of date and time of the pumpinternal clock. Depending on the type of implantable medical devicebeing employed other functionality may be adjusted or controlled.

Referring to FIG. 1 a, implantable drug infusion pump 100 is in wirelesscommunication with a universal external control device 200 to be used bymultiple conditional access users. Each conditional access user isprovided with a single access device 300 which is a physical device forrestricting or permitting access to certain functionality associatedwith the implantable medical device by the user in possession of thedevice. The inventive access device eliminates the need for any oneconditional access user to carry multiple keys or cards, one associatedwith each function. In a first embodiment the access device 300 is a keyor card inserted in a complementary size and shape slot defined in theexternal control device 200. The key or card 300 includes a set ofmagnets 315 whose number, polarity and/or position is encoded for theparticular user and associated functionality to which that user ispermitted or restricted access. FIGS. 1 b-1 e show four exemplaryembodiments of the access device 300 of FIG. 1 a, each having adifferent number of magnets and/or arrangement to uniquely identifymultiple conditional access users. By way of example, FIG. 1 b depictsan access device for a physician including three magnets 315 arranged ina triangular configuration. The access device provided to thetechnician, as shown in FIG. 1 c, has five magnets 315 arranged in a “T”configuration. FIG. 1 d is an access device for use in the factoryduring manufacture of the implantable medical device and includes fourmagnets 315, wherein three are arranged in a substantially linearconfiguration with the third displaced a predetermined distance from theother three. Lastly, FIG. 1 e depicts an exemplary access device for asales representative in which once again only three magnets 315 areemployed, however, in contrast to that shown in FIG. 1 b, theirpositioning differs. Any number of magnets and their positioning may bealtered, as desired, to differentiate between multiple conditionalaccess users. The access device 300 may be manufactured with apredetermined number of recesses 310 in a predetermined arrangement toaccommodate all possible configurations. During manufacture, theappropriate number of magnets 315 complementary in shape and size needonly be secured within the appropriate recesses to form the uniquearrangement.

In operation the external control device 200 senses thepresence/polarity of the magnets by Hall sensors disposed in the slot.To prevent improper recognition based on extraneous external magneticfields, the external control device 200 may include a security hallsensor. The magnetic detection access device shown in FIGS. 1 b-1 e isadvantageous in that it does not require an electrical contact betweenthe key and external control unit that may be hampered by the presenceof debris (e.g., dust) or deterioration of the contact surface. Once theparticular user has been identified based on the number, placementand/or polarity of the magnets, a look-up-table (LUT) or some otherstorage means is used to retrieve the associated functionality to whichthat user is permitted or denied access.

Alternatively, access device 300 may be a smart card or other electronicidentification card. External control device 200 includes circuitry 205for reading the smart card 300 which includes circuitry and software forrestricting access to the functionality of the implantable medicaldevice 100 depending on the access accorded to the conditional accessuser in possession of the access device. The smart card 300 is insertedinto an opening such as a slot or remotely read by complementarycircuitry 205 associated with the universal external control device 200.A smart card is advantageous since it is disposable or reloadable andthus may be readily reconfigured for different users or updated withouthaving to issue a new physical card. Stored in a memory device 305 is aunique identifier of the user and/or level of implantable medical devicefunctionality to which the user possessing the card has access.Alternatively, the memory device 305 may store that functionality towhich the user possessing the card is prohibited from accessing. In afirst configuration, only a unique identification of the user is storedin the memory device 305 of the identification access device 300. Whenthe identification access device 300 is read by complementary circuitry205 associated with the external control device 200, based on the uniqueidentification of the user, the associated functionality which that useris permitted or restricted access is retrieved from a look-up-table(LUT) or other storage device 210 associated with the external controldevice 200. As an alternative configuration, the identification accessdevice 300 itself may store in associated memory 305 the functionalityfor which the user in possession of the device is permitted orrestricted access. In this latter example, the unique identity of theuser may, but need not necessarily, be stored in the memory of theidentification access device 300. Still other mechanisms may be used topermit conditional access to privileges or functionality, for example,the user could enter a password that permits access to certainfunctionalities.

Two generic frameworks may be employed when defining that conditionalfunctionality of the implantable medical device for which eachconditional access user is permitted or precluded from accessing. In afirst embodiment, each conditional access user is assigned a particularlevel from among multiple conditional functional access levelscomprising a hierarchical framework. The hierarchical framework may bedesigned, as desired, so that a single conditional access user isassigned to each conditional functional access level, or alternatively,more than one conditional access user may be assigned to any of theconditional functional access levels. Multiple conditional functionalaccess levels are included in a hierarchical framework comprising alowest/first conditional functional access level and a highest/lastconditional functional access level with any number of intermediateconditional functional access levels therebetween. A defaultnon-conditional functional access level may be employed for which thereis no conditional access, that is, the functionality associated with thedefault non-conditional functional access level is available to allusers, including non-conditional access users, e.g., typically apatient. This default non-conditional functional access level may beeliminated altogether, if desired.

Starting with the lowest or first conditional functional access leveleach successive or higher conditional functional access level in thehierarchical framework expands or increases the user's access tofunctionality associated with the implantable medical device. Thus, theconditional access user assigned or associated with the lowest or firstconditional functional access level has the most restricted access amongthe conditional access users, while the conditional access user assignedor associated with the highest or last conditional functional accesslevel has the greatest freedom and least restriction among theconditional access users to functionality of the. implantable medicaldevice. It is also contemplated and within the intended scope of theinvention to reverse the order so that the highest or last conditionalfunctional access level has the most restricted access whereas thelowest or first conditional functional access level has the greatestaccess and least restriction.

By way of illustrative example, the universal external control device200 is operable by four. different users, namely, a patient, aphysician, a sales representative and a technician. The patient in thisexemplary embodiment is classified as a non-conditional access userhaving access only to default access level functionality, i.e., thatfunctionality whose access is not restricted or prohibited among itsusers. Such default access level functionality may include turning offan alarm, setting of the internal clock for the pump (e.g., change oftime zone or day light savings time), and interrogating the status ofthe pump. External control device 200 using circuitry 205 is programmedto distinguish or recognize via access device 300 among three differentconditional access users, e.g., the physician, the sales representativeand the technician.

The hierarchy of three conditional functional access levels from thefirst/lowest to the third/last/highest assigned to the physician, salesrepresentative and technician, respectively, are shown in the exemplaryVenn diagram of FIG. 2. That is, the physician is assigned the lowest orfirst conditional functional access level of the hierarchy frameworkthat is the most restrictive of the three conditional functional accesslevels. At this first or lowest conditional functional access level inthe hierarchical framework, the physician's access in the illustrativeexample is limited to adjusting the volume dosage and time intervalbetween doses. Other functionality may be conditionally accessible bythe physician such as modification of the medication parameters (e.g.,type of medication, concentration of medication) or storing ofinformation about the implantation of the pump (patient's name, age,address, date of implantation, name of hospital where implantationoccurred, manufacturer of catheter, length of catheter, volume ofcatheter).

A next or second conditional functional access level in the hierarchicalframework is assigned in the illustrative example to the salesrepresentative. At this second conditional functional access level thesales representative is permitted access to all of the functionalityassociated with the first or lowest conditional functional access level.In addition, at the second conditional functional access leveladditional functionality such as modifying the name of the patient isavailable to the sales representative. Another exemplary functionassociated with the second conditional functional access level in theillustrative embodiment is the ability to engage in a self-testing modeto ensure or verify that the device is operating properly and thenanalyze the self-testing results. Any functionality associated with thesecond conditional functional access level and not the first or lowestconditional functional access level is therefore not available to thoseconditional access users assigned to the first or lowest conditionalfunctional access level. Accordingly, the physician will be precludedfrom modifying the name of the patient or triggering self-testingoperation.

The third or last conditional functional access level in thehierarchical framework is associated with the technician. In theexemplary embodiment, since the technician is assigned the highest orlast conditional functional access level in the hierarchical frameworkthe technician also has access to all the functionality associated withthe previous levels, e.g., the first and second conditional functionalaccess levels. It is advantageous for the technician to have full accessto all functionality so that they may perform such functions asresetting the system or testing of any of the components. In summary,lower level conditional access users are prohibited from accessing anyfunctionality associated with a higher access level than that level towhich they have been assigned. With each successive higher conditionalfunctional access level in the hierarchical framework additionalfunctionality will be available for access by the conditional accessuser assigned to that particular conditional functional access levelthat otherwise is prohibited or restricted access by lower access levelconditional access users. In a hierarchical framework conditional accessusers are permitted access to all functionality of conditional accesslevels in the framework lower than that level to which the user has beenassigned.

The conditional access users in the example described above and theirassociated conditional functionality are not exhaustive and thus theconcept of a hierarchical framework of multiple access levels may begenerically described with respect to any application or situation. Ingeneral, a hierarchical framework comprises at least two conditionalfunctional access levels including a first/lowest conditional functionalaccess level, a highest/last conditional functional access level and mayinclude any number of intermediate conditional functional access levels.A first conditional user's ability to control the functionality of theimplantable medical device is restricted to the first/lowest conditionalfunctional access level. This first conditional functional access levelis the most restricted among all of the multiple conditional functionalaccess levels and generically represented by the letter “a”, wherein theletter “a” defines a single function or a set of more than one functionof the implantable medical device. The functions associated with asecond conditional functional access level are represented by “a+b”,wherein “a” defines the functions associated with the first/lowestconditional functional access level, while “b” represents thosefunctions associated with the second conditional functional accesslevel, but not including the functions “a” associated with thefirst/lowest conditional functional access level. The nth or lastconditional functional access level in the hierarchical frameworkrepresents the least restrictive level which provides the associatedconditional access user with the most freedom and is represented by“a+b+ . . . n”. This nth or last conditional functional access level mayhave no restrictions whatsoever to the functionality of the implantablemedical device. in this generic description of a hierarchical frameworkcomprising multiple access levels the letters “a”, “b” . . . , “n” eachmay represent a single function or a set of more than one functionassociated with the implantable medical device and implemented by theuniversal external control device 200.

As an alternative to a hierarchical framework a non-hierarchicalframework may be employed wherein each of the multiple conditionalaccess users has conditional access to functionality some of which maybe overlapping among multiple conditional access users and others ofwhich may be available only to one conditional access user. By way ofillustrative example, the Venn diagram in FIG. 3 of the exemplarynon-hierarchical framework includes four sets of conditional accessfunctions. In contrast to the hierarchical framework described above,there are no functional access levels employed in the non-hierarchicalframework. Instead, each conditional access user is assigned to a set ofone or more conditional access functions for which access by thatconditional access user is permitted. For example, the physician may bepermitted to access, adjust or control a first set of conditional accessfunctions such as volume dosage and time interval between doses. Asecond set of conditional access functions is assigned in theillustrative example to the sales representative. Unlike thehierarchical framework described above, in the non-hierarchicalframework there is only a partial overlap of functionality shared by thefirst and second conditional access users, as represented by the areafilled in by horizontal lines. For. example, the sales representativemay be permitted to access volume dosage but not time interval betweendoses. In addition, the sales representative is permitted access toother functionality not accessible by the physician such as modifyingthe name of the patient or triggering a self-testing mode to ensure orverify that the device is operating properly and then analyze theself-testing results. The third set of conditional functional accesslevel in the non-hierarchical framework is associated with themanufacturer of the implantable medical device. In the example shown inFIG. 3 the manufacturer is not permitted access to the functionality ofthe other conditional access users but instead has its own restrictedfunctionality, for example, reprogramming of the implantable medicaldevice and its associated circuitry in the case of recall for improperor malfunction in operation. The last and fourth set of conditionalaccess functions is restricted to the technician. In this exemplaryembodiment, the technician is provided with access to some Of thefunctionality of the second set of conditional access functions (asrepresented by the area filled by horizontal lines) such as triggering aself-testing mode to ensure or verify that the device is operatingproperly but is not able to access any of the functionality of the firstand third sets of conditional access functions. In summary, with thenon-hierarchical framework multiple conditional access users areassigned conditional functional access independently of each otherwhereby there may, but need not necessarily be, any overlap orcommonality of conditional functionality among the conditional accessusers.

In operation, if no identification access device is being read, then theexternal control device 200 is in default mode whereby all usersincluding both non-conditional access users such as a patient and allconditional access users have access to that functionality that does notrequire satisfaction of a condition in advance. However, the flow chartdepicted in Figure describes the operation of the system in the case ofconditional access users. As a preliminary matter, in step 400 each ofthe multiple conditional access users is assigned a conditional accesslevel or a set of conditional access functions for which conditionalaccess is permitted by that user. Prior to gaining access to conditionalfunctionality associated with the implantable medical device, anyconditional access user is identified or recognized via the accessdevice 300 from which the conditional access level or set of conditionalfunctions is detected when placed in communication with the universalexternal control device 200, in step 410. Based on the conditionalfunctional access set or level detected from the access device in thepossession of the conditional access user access to conditionalfunctionality associated with the implantable medical device ispermitted or restricted in step 420. In the case of a hierarchicalframework each conditional access level is permitted access to thatfunctionality associated With its particular level and all lowerconditional access levels. However, in the alternative case of anon-hierarchical framework each set of conditional access functions maybe independent of any other or share some functionality of another setof conditional access functions.

Once again the present invention has been shown and described withrespect to control by multiple conditional access users of animplantable drug infusion pump, however, the present inventive universalexternal control device may be employed with any other type ofimplantable medical device. The universal external control devicepermits multiple conditional access users to have restricted access tospecific functionality of the implantable medical device without theneed for multiple keys one for each functionality to be carried by eachuser.

Thus, while there have been shown, described, and pointed outfundamental novel features of the invention as applied to a preferredembodiment thereof, it will be understood that various omissions,substitutions, and changes in the form and details of the devicesillustrated, and in their operation, may be made by those skilled in theart without departing from the spirit and scope of the invention. Forexample, it is expressly intended that all combinations of thoseelements and/or steps that perform substantially the same function, insubstantially the same way, to achieve the same results be within thescope of the invention. Substitutions of elements from one describedembodiment to another are also fully intended and contemplated. It isalso to be understood that the drawings are not necessarily drawn toscale, but that they are merely conceptual in nature. It is theintention, therefore, to be limited only as indicated by the scope ofthe claims appended hereto.

Every issued patent, pending patent application, publication, journalarticle, book or any other reference cited herein is each incorporatedby reference in their entirety.

1. A universal external control device for permitting wirelessconditional access to functionality of an implantable medical device bya plurality of conditional access users, comprising: circuitry foridentifying each of the plural conditional access users, determiningfunctionality associated with the implantable medical device which eachof the plural conditional access users has been assigned and restrictingaccess for each of the plural conditional access users to thatfunctionality associated with the implantable medical device based onthe determined functionality to which each of the plural conditionalaccess users has been assigned; each of the plural conditional accessusers is assigned by the circuitry a particular set of conditionalaccess functions from a non-hierarchical framework; wherein anon-conditional access user is assigned by the circuitry defaultnon-conditional functional access to the implantable medical devicewhich functionality does not require satisfaction of a condition inadvance and is accessible by the plural conditional access users.
 2. Thedevice in accordance with claim 1, wherein the circuitry includes Hallsensors for uniquely identifying each of the plural conditional accessusers.
 3. The device in accordance with claim 1, wherein thenon-hierarchical framework includes a first set of conditional accessfunctions and a last set of conditional access functions.
 4. The devicein accordance with claim 1, wherein any one set of conditional accessfunctions overlap in some part or be independent of any other set ofconditional access functions.
 5. A method for using a universal externalcontrol device for permitting wireless conditional access tofunctionality of an implantable medical device by a plurality ofconditional access users, comprising the steps of: assigning to each ofthe plural conditional access users functionality associated with theimplantable medical device to which that user is permitted conditionalaccess; the assigning step comprises assigning to each of the pluralconditional access users a particular set of conditional accessfunctions from a non-hierarchical framework; determining functionalityassociated with the implantable medical device which each of the pluralconditional access users has been assigned; and restricting access tothe functionality associated with the implantable medical device foreach of the plural conditional access users based on the determinedfunctionality to which each of the plural conditional access users ispermitted conditional access, wherein a non-conditional access user isassigned default non-conditional functional access to the implantablemedical device which functionality does not require satisfaction of acondition in advance and is accessible by the plural conditional accessusers.
 6. The method in accordance with claim 5, wherein thenon-hierarchical framework includes a first set of conditional accessfunctions and a last set of conditional access functions.
 7. The methodin accordance with claim 6, wherein the non-hierarchical frameworkincludes at least one intermediate set of conditional access functions.8. The method in accordance with claim 5, wherein any one set ofconditional access functions overlap in some part or be independent ofany other set of conditional access functions.
 9. The method inaccordance with claim 5, wherein the determining step comprises readingfrom an access device in communication with the universal externalcontrol device that functionality associated with the implantablemedical device which each of the plural conditional access users hasbeen assigned.
 10. A system for permitting wireless conditional accessto functionality of an implantable medical device by a plurality ofconditional access users, the system comprising: a plurality of accessdevices one for identifying each of the plural conditional access users;and a universal external control device including circuitry foridentifying the conditional access user based on the associated accessdevice when placed in communication with the universal external controldevice, determining functionality associated with the implantablemedical device which each of the plural conditional access users hasbeen assigned and restricting access for each of the plural conditionalaccess users to that functionality associated with the implantablemedical device based on the determined functionality to which each ofthe plural conditional access users has been assigned; each of theplural conditional access users is assigned by the circuitry aparticular set of conditional access functions from a non-hierarchicalframework; wherein a non-conditional access user is assigned by thecircuitry default non-conditional functional access to the implantablemedical device which functionality does not require satisfaction of acondition in advance and is accessible by the plural conditional accessusers.
 11. The system in accordance with claim 10, wherein the accessdevice permits access to more than one function of the implantablemedical device.
 12. The system in accordance with claim 10, wherein anyone set of conditional access functions overlap in some part or beindependent of any other set of conditional access functions.
 13. Thesystem in accordance with claim 10, wherein the non-hierarchicalframework includes a first set of conditional access functions and alast set of conditional access functions.
 14. The device in accordancewith claim 13, wherein the non-hierarchical framework includes at leastone intermediate set of conditional access functions.
 15. The device inaccordance with claim 1, wherein the functionality and access thereto isspecifically tailored to each of the plural conditional access userswithout having to change access to functionality associated with any ofthe other plural conditional access users.
 16. The method in accordancewith claim 5, wherein the functionality and access thereto isspecifically tailored to each of the plural conditional access userswithout having to change access to functionality associated with any ofthe other plural conditional access users.
 17. The device in accordancewith claim 10, wherein the functionality and access thereto isspecifically tailored to each of the plural conditional access userswithout having to change access to functionality associated with any ofthe other plural conditional access users.
 18. The device in accordancewith claim 1, wherein the conditional access users includes physicians,sales representatives and technicians; each physician having access tothe same functionality, each sales representative having access to thesame functionality and each technician having access to the samefunctionality.
 19. The method in accordance with claim 5, wherein theconditional access users includes physicians, sales representatives andtechnicians; each physician having access to the same functionality,each sales representative having access to the same functionality andeach technician having access to the same functionality.
 20. The devicein accordance with claim 10, wherein the conditional access usersincludes physicians, sales representatives and technicians; eachphysician having access to the same functionality, each salesrepresentative having access to the same functionality and eachtechnician having access to the same functionality.
 21. The device inaccordance with claim 1, wherein the conditional access functions anddefault non-conditional functional access functionality are set duringmanufacture.
 22. The device in accordance with claim 1, wherein thedefault non-conditional functional access, whose access is notrestricted or prohibited, is accessible by all users.
 23. The device inaccordance with claim 1, wherein the default non-conditional functionalaccess of which no conditions are in place to preclude access to thatfunctionality is accessible by all users.
 24. The device in accordancewith claim 1, wherein the default non-conditional functional access isavailable when no identification access is read.